Xeris Biopharma Holdings, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

Great, thanks. That is a great question. Thanks, Brandon. Thanks for having us here. This really lies in our strategy, and we kind of laid out our strategy about a year and a half ago of driving the growth of this business, and it starts with our commercial engine. We have three products that are growing, and as you just pointed out, we are guiding to at least 33% growth this year in revenue on top of 50 some growth, 40%, 50% growth last year. We see that growth continuing, and we continue to make that investment. We have three products. All three of them are growing. GVOKE, KEVEYIS, and RECORLEV. RECORLEV is driving the majority of the growth and the product that we really got behind, and we talked about that a year and a half ago.

We see that on path to getting to $1 billion, and we have that product on path with $750 million in total revenue by 2030 with RECORLEV on path to $1 billion. That, coupled with our gross margins, which are 85% and improving, really allows us to invest. Invest not only in our growth going forward, but our pipeline, which is what led us to last week, where we outlined the whole critical development program for XP-8121, once-weekly subcutaneous levothyroxine for hypothyroidism. We drew a picture for an unmet need of 3 million to 5 million people with an unmet need of being able to get into range that leads to a $1 billion to $3 billion opportunity. You see that this growth, the right margins, allows us to invest for growth plus our pipeline, and that is where we are at. This is the next inflection point.

Where is it taking us? It is taking us to a heavy expansion and growth, people across the company to run all the programs we are running, as well as our development program, and we are able to fund it within our company. It is an exciting time as we scale up to kind of get to that next level.

Yeah. We laid out a very comprehensive development plan because we're really focused on developing this product in a way that we can get after the unmet need, which is the people that can't get into range, for TSH specifically. So we laid out a program that gets us regulatory approval. That's the first and foremost thing we got to do, is get through the agency. We've worked that out with them. That's a non-inferiority study with Capstone. That's what we need to get to market because the space is, from a clinical standpoint, it's very intuitive. They have all these patients that they can't get into range. The medical guidelines say if you're out of range, you're at risk, so you need to get them in range.

We're in a scenario where if we just get regulatory approval, it's logical to them that, well, if I bypass the GI with a once-weekly subQ, I can get many of these patients who have GI issues or GI absorption issues getting in the way of getting people in range, so that I can get them on, like 8121. So it's very intuitive to them. They don't have a solution today. The daily orals are failing for these patients and in this space, and this is where our product fits in. We just need to get through approval. But that's not good enough. That's why we put in the rest of the clinical program, Touchstone.

We're going to spend a lot between now and approval on real-world evidence to help really identify and be able to lay out what the real unmet medical need is in this space, because nobody's done any clinical work in this ever. Right? Most of the products that are out there, all of them are approved based on-- they're pre-DESI and they're based on PK/PD going all the way back to the original product, SYNTHROID.

Well, there's a lot in there.

Yeah. I'm going to miss some things.

So let's start with at a minimum. We'll have differentiation in the label because we'll have a once-weekly subQ versus a daily oral. That in and of itself will eliminate some of the things that get in the way of GI absorption. So DDIs and things like that. There'll be differentiation in the label there. Touchstone is designed so that one of the things we saw in our phase II was there was a 40% screen failure. So patients were deemed to be in control on their current therapy, and then once they got into the trial, they weren't. This is a place which we know this is very common here, so Touchstone would be a great place to take people who can't get into control or are deemed not in control to take them in and do another study.

How that lands in the label, to be determined. We got to do the study, see where that lands, and see what it would add to the label. But it would be additive to the label that you would expect for levothyroxine hormone replacement. So that would be additive data. As well as any secondary endpoints we'll pick up in this year-long clinical trial in Cornerstone, those would be all additive and could be added into the label. But to be determined there as we get through the data.